Naropin® now approved for intrathecal (spinal) administration in the European Union (EU)

03/03/04

Södertälje, Sweden, 3 March 2004 - AstraZeneca announced today that its long-acting local anaesthetic Naropin® (ropivacaine) 5.0 mg/ml was recommended for approval in all EU member states for a new route of administration, intrathecal (spinal) administration. This is an extended clinical use within the indication surgical anaesthesia.

"Naropin® has the potential to become the drug of choice for spinal anaesthesia using various doses for different clinical situations," commented Kjell Ahlén, Global Medical Director for Anaesthesia. "It is anticipated that Naropin® for spinal anaesthesia will be welcomed as an effective and safe drug both in patients who receive operations on a day case basis as well as in patients who have to stay hospitalised following major surgery."

In clinical studies, Naropin® was shown to provide excellent spinal anaesthesia and muscular relaxation for orthopaedic, gynaecological or urological surgery and was well tolerated. A dose interval of 15-25 mg seems adequate to achieve good surgical anaesthesia. Naropin® has a favourable efficacy and safety profile.

Naropin® is currently approved for epidural anaesthesia during surgery and post-operative pain relief, pain relief in childbirth, Caesarean section, local infiltration anaesthesia, for surgery using peripheral nerve block techniques and for continuous peripheral nerve block for post operative pain relief.

The Netherlands acted as the Reference Member State in the Mutual Recognition procedure for European approval and Naropin® has already received approval for this new route of administration in Finland, New Zealand, Switzerland, Sweden, Iceland, Mexico, Argentina and Australia.

Naropin® is the latest addition to the AstraZeneca portfolio of anaesthetics, and its sales increased by 36% in 2003, to $106 million. AstraZeneca is the global leader of the worldwide anaesthesia market with a total market share of 31%. Other AstraZeneca anaesthesia products include the IV anaesthetic, Diprivan®, the topical anaesthetic cream, EMLA®, and the local anaesthetics Xylocaine®, Marcaine®, Carbocaine®, and Citanest®. Total sales of the Anaesthesia portfolio in 2003 was $941 million.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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